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Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Sponsor: Ottawa Heart Institute Research Corporation
Summary
HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.
Official title: Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-07-30
Completion Date
2027-03-31
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
Hemiarch repair
Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.
Extended arch repair
Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.
Locations (4)
London Health Sciences Centre
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Quebec, Canada